Clinical Research Coordinator II - Cancer Center-28541

Responsibilities

• Coordinates all aspects of the study including recruitment, consent, screening, scheduling, tracking, and provides study updates to study participants throughout the conduct of the study.
• May collect and enter data into study case report forms and/or electronic data capture system and respond to queries in a timely manner.
• Independently submits or partners with a regulatory coordinator to submit study related documents, study protocols, and study protocol amendments to the IRB per policy and procedure, with increasing autonomy over time to prepare for independent regulatory management responsibilities.
• Ensures procedural documentation is accurate, complete, and in compliance with institutional, local, state, and federal guidelines and regulations related to clinical research.
• Verifies and ensures that data is consistent with 100% of source documentation before entry into case report forms and electronic data capture systems to support accuracy, timeliness, and audit readiness.
• May collect, process, and ship potentially biohazardous specimens.
• May administer more complex structured tests and questionnaires according to research study protocols, including providing protocol-specific education to participants regarding procedures and expectations.
• Utilizes study-related technology and equipment as part of assessment procedures.
• Provides ongoing study status updates, responds to questions, and may create summary report(s) for distribution to the PI, Administrator, department stakeholders, Sponsor, and Compliance throughout the conduct of the study.
• Organizes and participates in auditing and monitoring visits.
• Makes sure participant interactions are monitored for protocol deviations, adverse events (AEs), and serious adverse events (SAEs), and reports findings per institutional and regulatory guidelines.
• Partners with PI(s), sponsor, compliance, clinical staff, and manager to identify and improve more complex processes as it relates to the conduct of the research study.
• May provide oversight, training, and coaching to less experienced staff.

Qualifications

• Bachelor’s degree
• 2+ years of experience coordinating clinical trials
• Independent site management experience OR 3 years total experience in coordinating clinical trials with increasing complexity
• Knowledge of Good Clinical Practices (GCP) and proper research documentation
• Basic knowledge of NIH and FDA rules and guidelines applicable to research
• Ability to manage timelines, keep track of tasks, and handle multiple study activities at once
• Ability to solve problems and make thoughtful decisions
• Closely pay attention to detail and organize study data and records
• Ability to build trust with participants and communicate respectfully with sponsors and outside partners
• Clear communication skills when sharing information with research teams, participants, or external groups
• Good teamwork skills, willing to work evenings or weekends if required
• Able to travel locally or nearby for study visits, participant support, or training

Preferred Qualifications

• 2-5 years’ experience in clinical research conduct, regulatory management, or research administration
• Relevant certification (Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), OR Certified IRB Professional (CIP))